FDA issues dietary supplements final rule – too little, too late

After waiting an incredible 13 years since Congress mandated better dietary safety rules, the FDA has finally released new regulations concerning the ingredients used in vitamins and dietary supplements such as herbs. But to say that these rules are anti-climactic would be a gross understatement. These rules are way too little and way too late. The new rules only cover manufacturing quality. “This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. Wow! It took over a decade for FDA to come up with rules to ensure that the products you purchase “contain what is on the label!”

How about some idea as to whether those products actually do anything or whether they are safe to take? I guess that’s too much to ask. “Even with these new manufacturing practices, there will be no assurance that dietary supplements work or are safe,” said Sidney Wolfe, M.D., Director of the Health Research Group at Public Citizen. “Congress mandated in 1994 that the agency issue a rule governing the manufacturing practices of dietary supplements. It is baffling that the FDA has taken until 2007 to finalize it,” he said.

Apparently, until now you had no idea whether the dietary supplements clogging the pharmacy shelves were even made properly, let alone whether they could do anything for you. “The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition. It’s about time! But, by the way, these final requirements will not apply to all manufacturers until 2010. We wouldn’t want to rush into anything, now would we?

And, of course, even these rules only go so far. Here’s what Senator Dick Durbin (D-IL) had to say: “The dietary supplement industry will have significant latitude to determine what quality control measures are appropriate, and limited resources will limit FDA’s ability to follow up on complaints. Too many in the dietary supplement industry have demonstrated time and again that they are motivated more by the health of their bottom line than the health of American consumers.”

We’ve now taken the smallest of baby steps towards properly regulating the Wild West marketplace of dietary supplements. But remember, supplements do not have to be proven either safe or effective before they can be sold, as medicines do, and the new rules will not change that.

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ABOUT THE AUTHOR

Ed Zimney, MD

Ed is a physician with more than 30 years of experience. He’s held positions in drug advertising review, drug safety surveillance, medical information and marketing with several bio/pharmaceutical companies.

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